A. Ahmed, M. Nassar, A. El-Olemy, Mohamed S. Emara
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引用次数: 1
摘要
建立了一种灵敏、精确、准确的气相色谱-质谱联用方法,用于同时测定纯样品和制剂中左旋咪唑和羟氯胺的含量。气相色谱是一种简便的分离分析方法,可在较短的分析运行时间内同时分析药物。在本研究中,分离使用ZB5柱(30 m ×0.53 mm, 1.50µm),氦气作为载气。该方法具有良好的药物分离性和准确性。结果表明,该方法具有良好的线性(r 2 = 0.9998)、精密度(RSD < 0.496%)、准确度(左旋咪唑的回收率为99.37%,羟氯胺的回收率为100.14%)、专属性和稳健性。左旋咪唑的LOD和LOQ分别为0.935 ng mL -1和3.085 ng mL -1,羟氯胺的LOD和LOQ分别为0.884 ng mL -1和2.917 ng mL -1。该方法分离效果好,准确度高。根据ICH指南对该方法进行了验证,并用于确定其药物制剂中的引用药物。
SIMULTANEOUS DETERMINATION OF LEVAMISOLE AND OXYCLOZANIDE IN THE PHARMACEUTICAL PREPARATION BY GC-MS
A sensitive, precise, and accurate gas chromatography-mass spectrometry method was developed for the simultaneous determination of levamisole and oxyclozanide in pure samples and pharmaceutical preparation. Gas chromatography was presented as a simple separation analytical method for the simultaneous analysis of the deliberated drugs within a shorter analytical run time. In this study, separation was achieved using a ZB5 column with (30 m ×0.53 mm, 1.50 µm), and helium as a carrier gas. The proposed method showed well separation between the drugs and each other and had good accuracy. The method showed to be linear (r 2 = 0.9998), precise (RSD < 0.496%), accurate (recovery of 99.37% for levamisole and 100.14% for oxyclozanide), specific and robust. LOD and LOQ values were 0.935 ng mL -1 and 3.085 ng mL -1 respectively for levamisole and 0.884 ng mL -1 and 2.917 ng mL -1 respectively for oxyclozanide. The proposed method obtained well separation and had perfect accuracy. The method was validated according to ICH guidelines and carried out to determine the cited drugs in their pharmaceutical preparation.